OBJECTIVE To observe therapeutic efficacy and safety of transcatheter arterial chemoembolization (TACE) com-bined with high intensity focused ultrasound (HIFU) in the treatment of middle and advanced primary hepatocellular carcinoma (HCC). METHODS:76 patients with middle and advanced primary HCC were randomly divided into treatment group(36 cases) and control group(40 cases). Control group was given TACE alone,and treatment group was additionally given HIFU 2-3 weeks after TACE. Clinical efficacy,the content of alpha-fetoprotein(AFP)before and after operation,survival rate,survival period and ADR were compared between 2 groups. RESULTS:The efficiency rate and total effective rate of treatment group were 61.1% and 94.4%,which were significantly higher than those of control group(35.0%,77.5%),with statistical significance(P<0.05). The content of AFP in 2 groups decreased significantly after operation,with statistical significance(P<0.05);there also was statistical significance between 2 groups(P<0.05). Survival rate of treatment group was higher than that of control group 24 and 36 months after operation,with statistical significance (P<0.05). The median survival time was 11.3 months in treatment group and 9.2 month in control group,with no statistical difference(P>0.05). No obvious ADR was found in 2 groups. CONCLUSIONS:Com-pared with TACE alone,TACE combined with HIFU in the treatment of middle and advanced primary HCC can improve long-term survival rate and the short-term efficacy,with good safety.